SIMBRINZA

Following topical ocular administration, brinzolamide is absorbed into the systemic circulation. Due to its affinity for CA-II, brinzolamide distributes extensively into the Red Blood Cells (RBC) and exhibits a long half-life in whole blood (approximately 111 days). In humans, the metabolite N-desethyl brinzolamide is formed, which also binds to CA and accumulates in RBCs. This metabolite binds mainly to CA-I in the presence of brinzolamide. In plasma, both parent brinzolamide and N-desethyl bri...

Two clinical trials of 3 months duration were conducted in patients with open-angle glaucoma or ocular hypertension to compare the IOP-lowering effect of SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% dosed three times daily to individually administered 1% brinzolamide three times daily and 0.2% brimonidine tartrate three times daily. Mean IOP values at baseline are presented in Table 1. Table 1. Mean (SD) IOP values at baseline SIMBRINZA Brinzolamide Brimonidine Study 1 (n=209) (n=224) (n=216) 8 AM 26.9 (2.63) 27.1 (2.64) 27.0 (2.56) 10 AM 25.3 (2.76) 25.4 (2.74) ...

Most common adverse reactions occurring in approximately 3% to 5% of patients included blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly co...

Hypersensitivity to any component of this product. (4.1) Neonates and infants (under the age of two years). (4.2) 4.1 Hypersensitivity SIMBRINZA is contraindicated in patients who are hypersensitive to any component of this product. 4.2 Neonates and Infants (under the age of two years) SIMBRINZA is contraindicated in neonates and infants (under the age of two years ) [see Use in Specific Populatio...

Potential for sulfonamide hypersensitivity reactions because of the brinzolamide component (5.1) Potential for corneal endothelium cell loss (5.2) Severe renal impairment may limit the metabolism of the brinzolamide component (5.3) 5.1 Sulfonamide Hypersensitivity Reactions SIMBRINZA contains brinzolamide, a sulfonamide, and although administered topically is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical adminis...

7 DRUG INTERACTIONS Oral Carbonic Anhydrase Inhibitors (7.1) High-dose Salicylate Therapy (7.2) Central Nervous System Depressants (7.3) Antihypertensives/Cardiac Glycosides (7.4) Tricyclic Antidepressants (7.5) Monoamine Oxidase (MAO) Inhibitors (7.6) 7.1 Oral Carbonic Anhydrase Inhibitors There is a potential for an additive effect on the known systemic effects of carbonic anhydrase inhibition i...